Few areas of healthcare change as fast as digital health, and few areas of law struggle harder to keep up. Telehealth, remote patient monitoring, AI-assisted diagnostics and documentation, digital therapeutics, and health data platforms are reshaping how care is delivered — but the regulatory framework governing them is a patchwork of older statutes never written with these technologies in mind, newer guidance that shifts frequently, and state-by-state variation that makes a single national compliance strategy nearly impossible.

That uncertainty creates real risk. A telehealth prescribing flexibility that exists today may expire on short notice. An AI tool used for clinical documentation or decision support may trigger licensing, liability, or data governance obligations its developers never anticipated. A digital health platform that looks like a straightforward software product to its engineers may look like a regulated healthcare service to a state licensing board.

MDRXLaw works with both sides of this landscape: digital health companies building new products and services, and healthcare providers and organizations adopting new technology into existing practices. The firm's approach is to translate fast-moving technical and regulatory developments into practical guidance clients can act on — not just flag the risk, but help structure the business to manage it.

How We Help

• Telehealth Regulation

  Advising on telehealth licensure, cross-state practice, and prescribing rules, including DEA telehealth flexibilities and their periodic extensions.

• AI Governance & Compliance

  Helping providers and technology companies understand compliance obligations for AI-driven clinical, diagnostic, and administrative tools under existing legal frameworks, including standards increasingly treated as baseline requirements rather than best practices.

• Data Privacy & Security

  HIPAA compliance, data-sharing agreements, and guidance on frameworks like SOC 2 that build the trust digital health platforms need with providers, payers, and patients.

• Remote Patient Monitoring & Digital Therapeutics

  Regulatory classification, reimbursement pathways, and compliance structuring for RPM and digital therapeutic products.

• Vendor & Technology Agreements

  Drafting and negotiating agreements between healthcare organizations and technology vendors, including business associate agreements and service-level terms.

• Corporate Structuring

  Advising digital health companies on corporate practice of medicine restrictions, licensure requirements, and multi-state operating structures.

• Regulatory Investigations & Enforcement Defense

  Representing digital health companies and providers in state and federal inquiries related to technology-enabled care delivery.

• Fraud & Abuse Compliance

  Anti-Kickback Statute, Stark Law, and False Claims Act analysis for technology-driven referral, marketing, and reimbursement arrangements.

• Business & Corporate Transactions

  Financing, M&A, and partnership structuring for digital health companies at every stage of growth.

• Litigation & Dispute Resolution

  Representing digital health companies and their provider partners in contract and technology disputes, including through MDRXResolve, our dedicated mediation platform for healthcare providers.

Digital health doesn't wait for the law to catch up, and neither do MDRXLaw's clients. The firm's role is to help them move forward with a clear-eyed understanding of where the legal lines actually are — today, and as they shift.